Safety and Effectiveness of Recombinant Human Growth Hormone in Children with Turner Syndrome: Data from the PATRO Children Study.

ABSTRACT:

Introduction

PATRO Children is an international, observational, postmarketing surveillance study for a biosimilar recombinant human growth hormone (rhGH; somatropin, Omnitrope®; Sandoz), approved by the European Medicines Agency in 2006. We report safety and effectiveness data for patients with Turner syndrome (TS).

Methods

The study population included infants, children, and adolescents with TS who received Omnitrope® treatment according to standard clinical practice. Adverse events (AEs) were monitored for safety evaluation, and height velocity (HV), height standard deviation score (HSDS), and HVSDS were calculated to evaluate treatment effectiveness.

Results

As of August 2019, 348 TS patients were enrolled from 130 centers. At baseline, 314 patients (90.2%) were pr

SUBMITTER: Backeljauw P 

PROVIDER: S-EPMC8491505 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature